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What is baclofen? Baclofen is a muscle relaxer and an antispastic agent. Baclofen is used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness. Baclofen may also be used for purposes not listed in this medication guide. Important information Baclofen may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of baclofen. Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone. Slideshow: Living with Your Migraines: Tips for Treatment and Prevention Living with Your Migraines: Tips for Treatment and Prevention You may have withdrawal symptoms such as seizures or hallucinations, when you stop using baclofen after using it over a long period of time. Do not stop using baclofen without first talking to your doctor. You may need to use less and less before you stop the medication completely. Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk. Before taking this medicine You should not use baclofen if you are allergic to it. To make sure you can safely take baclofen, tell your doctor if you have any of these other conditions: kidney disease; epilepsy or other seizure disorder; or a history of stroke or blood clots. Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk. FDA pregnancy category C. It is not known whether baclofen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether baclofen passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using baclofen. Do not give this medication to a child younger than 12 years old. Older adults may be more sensitive to the effects of this medicine. See also: Pregnancy and breastfeeding warnings (in more detail) How should I take baclofen? Take baclofen exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Call your doctor if your muscle symptoms do not improve after 2 weeks of taking baclofen. Do not stop taking this medication without first talking to your doctor. You may have withdrawal symptoms such as seizures or hallucinations, when you stop using baclofen after using it over a long period of time. You may need to use less and less before you stop the medication completely. Store baclofen at room temperature away from moisture and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include muscle weakness, vomiting, drowsiness, dilated or pinpoint pupils, weak or shallow breathing, fainting, or coma. What should I avoid? Baclofen may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of baclofen. Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone. Baclofen side effects * Get emergency medical help if you have any of these signs of an allergic reaction to baclofen: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: seizure (convulsions); confusion, hallucinations; or an uneven heartbeat. Less serious baclofen side effects may include: drowsiness, dizziness, weakness, tired feeling; headache; sleep problems (insomnia); nausea, constipation; or urinating more often than usual. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. See also: Side effects (in more detail) Baclofen dosing information Usual Adult Dose of Baclofen for Muscle Spasm: Oral: Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day. Maintenance dose: 40-80 mg/day. 80 mg/day doses should be administered in 4 divided doses. Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response. Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later. Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy. The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day. Usual Adult Dose of Baclofen for Trigeminal Neuralgia: Oral: Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day. Maintenance dose: 40-80 mg/day. 80 mg/day doses should be administered in 4 divided doses. Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response. Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later. Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy. The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day. Usual Adult Dose of Baclofen for Hiccups: Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day. Maintenance dose: 40-80 mg/day. 80 mg/day doses should be administered in 4 divided doses. Usual Adult Dose of Baclofen for Cerebral Spasticity: Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response. Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later. Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy. If a positive response has occurred following a test dose, an intrathecal infusion device may be surgically implanted. The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day. What other drugs will affect baclofen? Before using baclofen, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, other muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by baclofen. This list is not complete and other drugs may interact with baclofen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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